This trial will evaluate the safety, tolerability, and preliminary efficacy of tegavivint as monotherapy (single) and in combination with standard therapies in patients with metastatic colorectal carcinoma (mCRC).
Signed informed consent form (ICF)
Male or female, 18 years of age or older
Histologically and/or cytologically documented metastatic colorectal adenocarcinoma (all other histological types are excluded)
Disease progression or intolerance to ≥ 2 lines of systemic therapy for advanced/metastatic disease, including the following prior therapies unless contraindicated: fluoropyrimidine-, oxaliplatin- and irinotecan-based regimens, an anti-vascular endothelial growth factor (VEGF) therapy, and if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy.
Patients receiving therapy with other anti-neoplastic or experimental agents.
Patients receiving concomitant strong or moderate inhibitors of CYP3A4/5 that cannot be discontinued 7 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
Patients receiving concomitant strong or moderate inducers of CYP3A4/5 that cannot be discontinued at least 14 days prior to Cycle 1 Day 1.
Patients with known history of Gilbert's syndrome or other genetic conditions affecting UGT1A1 function.
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Treatment groupsSee each treatment group below.
HonorHealth Research Institute
Lead sponsor
Iterion Therapeutics
Collaborator